NCT06919354RecruitingPhase 1
A Study of GNTI-122 in Adults Recently Diagnosed With T1D
POLARIS: A Phase 1, Single Dose, Open-label Study of GNTI-122 in Adults With Recently Diagnosed Type 1 Diabetes (T1D)
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
This is a 78-week single arm, multi-center, Phase 1 study to evaluate the safety, tolerability, cellular kinetics, and biomarker changes in C-peptide over time of GNTI-122, an investigational cell therapy manufactured from a participant's own blood cells in adult participants with recently diagnosed T1D. After assessment of eligibility, participants who qualify for the study will be enrolled sequentially in 1 of 3 cohorts. Cohort 1 participants (n=3) receive a low dose of GNTI-122 . Cohort 2 participants (n=3) receive a high dose of GNTI-122. Cohort 3 participants (n=10) receive a high dose of GNTI-122 in combination with rapamycin. Participants are followed for 78 weeks after the administration of GNTI-122 during which safety and efficacy assessments are made, including vital signs, ECG, physical exam, clinical labs, and monitoring of adverse events and concomitant medications. Disease markers (e.g., MMTT-stimulated C-peptide, HbA1c) and pharmacodynamic activity (e.g., lymphocyte subsets and phenotypes, effector T cell responses to islet antigens ex vivo, T1D autoantibodies) will be monitored serially throughout the study. The study will include sentinel dosing and a Safety Review Committee to ensure participant safety. Visit https://www.polarisstudy.com to learn more!
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 25 Mar 2025
- Start date
- 3 Sept 2025
- Primary completion date
- Feb 2028
- Lead sponsor
- GentiBio, Inc
- Diseases
- Type 1 diabetes
- NCT number
- NCT06919354
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 16
- From 3 Sept 2025 to the primary completion date, Feb 2028
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Experienced DKA within 4 weeks prior to or during Screening.
- Participation in another clinical study or active follow-up in a prior study.
Other illness
- Type 2 diabetes.
- Chronic or uncontrolled medical condition.
- Has another active or autoimmune or inflammatory disease with the exception of well-controlled Hashimoto's thyroiditis, celiac disease, or vitiligo.
Other
- Unwilling or unable to comply with study procedures or schedule.
Who the study is looking for
- Male and female participants aged ≥18 to ≤55 years with recently diagnosed (within 180 days of Screening) T1D according to American Diabetes Association criteria.
- Participant has residual β-cell function during Screening, defined as random C-peptide ≥ 0.2 nmol/L.
- Positive for at least one T1D-associated autoantibody.
- Able and willing to provide written, informed consent as approved by the IRB.
- Is confirmed positive for the HLA-DRB1\*04:01 allele.
- Has adequate vascular access to undergo leukapheresis with no known contraindications.
- 8\. Female participants of childbearing potential must have a negative serum pregnancy test at Screening, must be not lactating, and must agree to protocol-specified contraception.
- 9\. Male participants of childbearing potential must agree to protocol specified contraception.
- 10\. Other than T1D, participant is in good general health.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Joslin Diabetes Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| University of Florida - Gainesville Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| University of Miami, Diabetes Research Institute Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| University of California San Diego Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.